Trials · 2025
Effectiveness of human albumin for clinical outcome in aneurysmal subarachnoid hemorrhages: a protocol for randomized controlled (HASH) trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Ali Arshad, Khan Mohsin, Shaikh Nissar, Mohamad Amr El, Al-Maadhadi Mazyona, Shah Noman, Al-Najjar Yousef, Salam Abdul, Al-Rumaihi Ghaya, Ayyad Ali, Belkhair Sirajeddin, Al-Sulaiti Ghanem
Аннотация
BACKGROUND: Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with an overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in the overall prognosis for aSAH. Cerebral vasospasm remains the predominant cause of associated morbidities. Human albumin has been used in different neurological conditions, including head trauma, intracerebral hemorrhages, and ischemic strokes, with favorable outcomes. However, its beneficial use in aSAH has not been sufficiently explored until recently a published systematic review by our team. In view of the scarcity of published data and lack of robust evidence, our group has designed the first-ever RCT to compare the use of human albumin-enhanced fluid management versus standard fluid therapy with crystalloids in patients with aSAH.
METHODS: This single-center open-label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha, Qatar, from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to be sufficient to detect a clinically significant difference in the modified Rankin scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhage patients. The primary outcome will be based on a dichotomized modified Rankin scale [good grades (0-2) and poor grades (3-6)], while the secondary outcome will include symptomatic vasospasm, transcranial Doppler velocities, and Pulse index Contour Cardiac Output (PiCCO) parameters.
DISCUSSION: The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve an optimal fluid management regime to explore its potential role in improving clinical outcomes in patients with aSAH.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06548477. Registered on August 9, 2024. https://clinicaltrials.gov/search?term=NCT06548477 .
METHODS: This single-center open-label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha, Qatar, from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to be sufficient to detect a clinically significant difference in the modified Rankin scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhage patients. The primary outcome will be based on a dichotomized modified Rankin scale [good grades (0-2) and poor grades (3-6)], while the secondary outcome will include symptomatic vasospasm, transcranial Doppler velocities, and Pulse index Contour Cardiac Output (PiCCO) parameters.
DISCUSSION: The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve an optimal fluid management regime to explore its potential role in improving clinical outcomes in patients with aSAH.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06548477. Registered on August 9, 2024. https://clinicaltrials.gov/search?term=NCT06548477 .